UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041568 |
|---|---|
| Receipt number | R000047084 |
| Scientific Title | Comparison on the occurrence of bleeding related events in influenza outpatients by treatment status using health insurance claims database |
| Date of disclosure of the study information | 2020/08/26 |
| Last modified on | 2022/05/10 11:08:52 |
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Basic information
Public title
Comparison on the occurrence of bleeding related events in influenza outpatients by treatment status using health insurance claims database
Acronym
Comparison on the occurrence of bleeding related events in influenza outpatients by treatment status using health insurance claims database
Scientific Title
Comparison on the occurrence of bleeding related events in influenza outpatients by treatment status using health insurance claims database
Scientific Title:Acronym
Comparison on the occurrence of bleeding related events in influenza outpatients by treatment status using health insurance claims database
Region
| Japan |
Condition
Condition
Influenza virus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the occurrence of bleeding related events in influenza outpatients by treatment status.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of bleeding related events
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients whose first diagnosis date for influenza (Day 1) was within the enrollment period (1st Oct 2017 to 11th April 2019)
2) Patients who received some outpatient consultation (medical care or drug prescription) on Day 1.
3) Patients who were continuously registered in the database for at least 6 months before Day 1
Key exclusion criteria
1) Patients who have another influenza diagnosis in the last 20 days before Day 1.
2) Patients who received anti-influenza drugs in the last 20 days before Day 1.
3) Patients who withdrew from the database before Day 20.
4) Patients who were hospitalized on Day 1.
5) Patients who received several anti-influenza drugs on Day 1.
Target sample size
1300000
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Urushihara |
Organization
Keio University, Faculty of Pharmacy
Division name
Drug Development & Regulatory Science Faculty of Pharmacy
Zip code
105-8512
Address
1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512, Japan
TEL
+81-3-5400-2649
urushihara.hisashi@keio.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Hara |
Organization
Shionogi & Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
541-0045
Address
1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL
+81-6-6209-6958
Homepage URL
kanae.hara@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Ethics Committee
Address
1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512, Japan
Tel
+81-3-3434-6241
skc-soumu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2020 | Year | 08 | Month | 26 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047084
